TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.

TPI 287

One subject, age 25, was allowed to enroll on study, but was censored from endpoints due to age.

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

To determine the safety, tolerability and maximum tolerated dose (MTD) of TPI 287 as a single agent and collect exploratory data on the safety and tolerability of TPI 287 in combination with temozolomide (TMZ) in pediatric and young adult patients with refractory or recurrent neuroblastoma or medulloblastoma

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Tmax of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Number of Patients With an Overall Response Rate (ORR) of PR or CR

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Progression Free Survival (PFS) of Participants Using Days From Start of Study Drug Until Progression

Cmax of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.

AUC of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.

Overall Study

Giselle Sholler, MD

Neuroblastoma

Medulloblastoma

Relapse

Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.

Rady Children's Hospital

Arnold Palmer Hospital for Children- MD Anderson

Cardinal Glennon Children's Medical Center

Levine Children's Hospital

Medical University of South Carolina

UVM/FAHC

TPI 287 in Patients With Refractory or Recurrent Neuroblastoma or Medulloblastoma

A Phase 1 Trial of TPI 287 as a Single Agent and in Combination With Temozolomide in Patients With Refractory or Recurrent Neuroblastoma or Medulloblastoma

baccatin/krūties vėžys

TPI 287 in Patients With Refractory or Recurrent Neuroblastoma or Medulloblastoma

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